National Institute on Deafness and Other Communication Disorders (NIDCD)

National Institutes of Health Clinical Center (CC)

NIH

Observational Model: Cohort

Time Perspective: Prospective

To permit evaluation of patients to NIDCD Head and Neck Branch in order to identify suitable candidates for NIDCD NCI Head and Neck protocols or other NCI-based Head and Neck Cancer protocols.

Evaluation of standard care treatment for subjects with head and neck disorders, train ENT surgeons and clinical associates in surgical intervention procedures and stimulate new ideas for clinical research

300

All

4 Years to 99 Years (Child, Adult, Older Adult)

NCT00011492

01009901-DC-0099

August 16, 2004

February 23, 2001

January 29, 2019

National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland, United States

Maximum-tolerated dose of lenalidomide with cetuximab, defined as the highest dose level at which 0 or 1 patients out of 6 experiences a dose limiting toxicity graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

Adverse events defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related graded according to Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0

PK of entolimod when administered in combination with cisplatin and radiation therapy

The percentage of patients with mucositis, measured using the World Health Organization (WHO) mucositis global severity score and the oral mucositis daily questionnaire (OMDQ)